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Getting the latest healthcare news for you
Getting the latest healthcare news for you
A new precision medicine option just landed for advanced breast cancer. The FDA has granted accelerated approval to camizestrant (Etcamah) combined with a CDK4/6 inhibitor for hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer harboring ESR1 mutations. The phase 3 SERENA-6 trial showed a 56% improvement in progression-free survival compared to standard of care.
Precision medicine scores a win in advanced breast cancer. The FDA has granted accelerated approval to camizestrant (Etcamah, AstraZeneca) in combination with a CDK4/6 inhibitor for adults with hormone receptor-positive (HR+), HER2-negative locally advanced or metastatic breast cancer — specifically in patients who develop ESR1 mutations during aromatase inhibitor and CDK4/6 inhibitor therapy. The approval hinges on detecting that mutation via cell-free DNA testing during first-line treatment.
The decision was based on results from the randomized phase 3 SERENA-6 trial, which enrolled 315 patients. Those who switched to camizestrant upon ESR1 mutation detection saw a median PFS of 16 months, compared to just 9.2 months for those who stayed on standard therapy — roughly 7 extra months of disease control. OS data are still maturing.
By the Numbers:
Why it matters: This approval validates a proactive, mutation-guided treatment switch strategy — essentially catching resistance early and acting on it. Experts say it could redefine the standard of care for HR+/HER2- advanced breast cancer and underscores the growing necessity of routine cell-free DNA testing in this patient population.
